ULTRACIN M by Cal Pharma ULTRACIN M- menthol gel

ULTRACIN M by

Drug Labeling and Warnings

ULTRACIN M by is a Otc medication manufactured, distributed, or labeled by Cal Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHOL (10%)

PURPOSE

TOPICAL ANALGESIC

USES

Temporarily relieves mild aches, pains, and in.ammation of muscle and joints associated with nerve damage and sport injuries.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a healthcare professional before use.

WARNINGS

For external use only. Do not use on open wounds, cuts, damaged or infected skin as well as in the eye, mouth, genitals or any other mucous membrane. Stop use and consult your physican if pain is persistent or worsens.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

DIRECTIONS

Adults and children over 12 years: Apply to a.ected area and gently massage over area until absorbed. Do not use more than 4 timesa day. Wash hands after gel is applied.

INACTIVE INGREDIENTS

Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, Boswelia Serrata Extract, Citrus Limon,Denatured Dehydrated Alcohol 40B, Gaultheria Procumbens (Wintergreen) Leaf Oil Extract, Petasites Japonicus Root (Butterbur) Extract,Pine (Pinetree) Bark Extract, Salix Nigra (Willow) Bark Extract, Zanthoxylum Americanum (Prickly Ash) Bark Extract, Zanthoxylum Bungeanum Fruit (Sichuan Peppercorn) Extract, Water

QUESTIONS OR COMMENTS?

1-888-551-7778

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRACIN M 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-9051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
LIME (CITRUS) (UNII: 8CZS546954)
ALCOHOL (UNII: 3K9958V90M)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)
MARITIME PINE (UNII: 50JZ5Z98QY)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)
ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-9051-4	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/29/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/29/2012

Labeler - Cal Pharma (078721283)

Registrant - Cal Pharma (078721283)